Bilateral Vestibulopathy, Functional Dizziness, Vertigo
Conditions
Keywords
real world evidence, non-interventional study, patient reported outcome
Brief summary
In this study the researcher observe how vertigo symptoms change during two months of treatment with the natural medicinal product Vertigoheel©. Adult patients suffering from vertigo symptoms can participate if they are diagnosed with bilateral vestibulopathy (BVP) or functional dizziness (FD) and assigned to Vertigoheel treatment. Participating patients receive an examination at study start and after 2 months of Vertigoheel treatment. The study focuses on patient reported outcomes assessed by questionnaires. Vertigo symptoms are assessed by the Dizziness Handicap Inventory questionnaire. Patients' quality of life is assessed by a questionnaire. Body sway is assessed by static posturography. FD patients are additionally tested for depressive and anxiety symptoms by questionnaires. BVP patients are additionally tested for vestibular function by video head impulse test and caloric testing. Adverse events and other observations related to safety (physical examination and vital signs) are evaluated. Vertigo is a common symptom with significant adverse effects on patients' quality of life. Regardless of the exact cause of vertigo attacks, it is important to reduce the frequency, intensity, and duration of vertigo attacks with an effective medication that has no or minimal adverse effect. Vertigoheel®, a natural medicinal product consisting of four ponderable active ingredients, is approved in Germany as treatment for vertigo of various origins. However, no systematic data are available for Vertigoheel® regarding patient-reported outcomes in BVP and FD as the most accepted endpoint in vertigo studies.
Interventions
None listed
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Treatment with Vertigoheel® has been chosen by the physician independently of including the patient in this non-interventional study. * Bilateral vestibulopathy or functional dizziness according to the current diagnostic criteria of the Bárány Society * Symptoms for \> 3 months of moderate to severe intensity according to the dizziness handicap inventory \[0 (minimum score) -100 (maximum score)\] between 30 to 90 points. * ≥18 years of age * Legally competent male or female outpatient. * Signed informed consent. * Not pregnant (as proven by negative pregnancy test in case of woman of childbearing potential before first study drug administration) or breast-feeding.
Exclusion criteria
* Having taken within the last 2 months or currently taking Vertigoheel®. * Debilitating acute or chronic illness (i.e. psychiatric illnesses). * History of sensitivity to any component of the study drug under observation. * Unwilling or unable to comply with all the requirements of the study protocol. * Any relationship of dependence with the sponsor or with the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dizziness Handicap Inventory | 2 months | Change from baseline in dizziness handicap inventory (DHI) after 2±1 months Vertigoheel® treatment. The DHI, ranging from 0 to 100 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoL) | 2 months | Change from baseline in quality of life (QoL) assessed by EQ-5D-5L after 2±1 months Vertigoheel® treatment. The EQ-5D index was used as described by Ludwig et al. (PharmacoEconomics, 2018, 36:663-74), ranging from -0.661 to 1.000, with higher scores indicating better quality of life. QoL was assessed at two time points: baseline and 2 months. |
| Postural Imbalance | 2 months | Change from baseline in body sway assessed by static posturography after 2±1 months Vertigoheel® treatment. Posturography was assessed as described by Brandt et al. (J Neurol 2012, 259:182-4) with an artificial neural network analysis. Category three of the method for peripheral vestibular deficit was evaluated for patients with bilateral vestibulopathy, and category five for phobic postural vertigo was evaluated for patients with functional dizziness. Posturography was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. Positive values indicate more swaying and negative values indicate less swaying. The higher the value, the more swaying (worse regulation of stand). The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change). |
| Depressive Symptoms in Functional Dizziness | 2 months | Change from baseline in depressive symptoms of functional dizziness patients assessed by PHQ-9 questionnaires after 2±1 months Vertigoheel® treatment. The PHQ-9, ranging from 0 to 27 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months. |
| Anxiety Symptoms in Functional Dizziness | 2 months | Change from baseline in anxiety symptoms of functional dizziness patients assessed by GAD-7 questionnaires after 2±1 months Vertigoheel® treatment. The GAD-7, ranging from 0 to 21 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vestibular Function in Bilateral Vestibulopathy by Video Head Impulse Test | 2 months | Change from baseline in vestibular function of bilateral vestibulopathy patients assessed by video head impulse test (vHIT) after 2 ± 1 months Vertigoheel ® treatment. The vHIT was performed as described by MacDougall et al. (Neurology, 2009, 73(14):1134-41) to evaluate the function of the vestibulo-ocular reflex (VOR) in the high frequency range for the horizontal semicircular canals. Based on previous HIT data from healthy, asymptomatic subjects, a normal VOR velocity gain was defined as 0.68 or greater (MacDougall et al.2009). Vestibular function was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change). |
| Vestibular Function in Bilateral Vestibulopathy by Caloric Testing | 2 months | Change from baseline in vestibular function of bilateral vestibulopathy patients assessed by caloric testing after 2 ± 1 months of Vertigoheel® treatment. Caloric testing was performed as described by Strupp et al. (J Vestib Res. 2017;27(4):177-89) to evaluate the function of the vestibulo-ocular reflex (VOR) in the low-frequency range of the horizontal semicircular canal on each side. Bilaterally reduced angular VOR function is a diagnostic criterion for bilateral vestibulopathy (BVP). Reduced caloric response, i.e., a sum of both responses per ear \<6◦/sec, can be considered a safe criterion for BVP. Vestibular function was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change). |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Functional Dizziness Patients diagnosed with functional dizziness according to the current diagnostic criteria of the Bárány Society. | 41 |
| Bilateral Vestibulopathy Patients diagnosed with bilateral vestibulopathy according to the current diagnostic criteria of the Bárány Society. | 13 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Diagnostic criteria not met at baseline | 0 | 8 |
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Bilateral Vestibulopathy | Total | Functional Dizziness |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 30 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 24 Participants | 19 Participants |
| Age, Continuous | 64.1 years STANDARD_DEVIATION 11.2 | 64.3 years STANDARD_DEVIATION 14 | 64.4 years STANDARD_DEVIATION 14.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 54 Participants | 41 Participants |
| Region of Enrollment Germany | 13 participants | 54 participants | 41 participants |
| Sex: Female, Male Female | 3 Participants | 22 Participants | 19 Participants |
| Sex: Female, Male Male | 10 Participants | 32 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 21 |
| other Total, other adverse events | 7 / 41 | 7 / 21 |
| serious Total, serious adverse events | 0 / 41 | 0 / 21 |
Outcome results
Primary
Dizziness Handicap Inventory
Change from baseline in dizziness handicap inventory (DHI) after 2±1 months Vertigoheel® treatment. The DHI, ranging from 0 to 100 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months.
Time frame: 2 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Functional Dizziness | Dizziness Handicap Inventory | -12.0 score on a scale |
| Bilateral Vestibulopathy | Dizziness Handicap Inventory | -13.2 score on a scale |
Secondary
Anxiety Symptoms in Functional Dizziness
Change from baseline in anxiety symptoms of functional dizziness patients assessed by GAD-7 questionnaires after 2±1 months Vertigoheel® treatment. The GAD-7, ranging from 0 to 21 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months.
Time frame: 2 months
Population: Data from 38 patients were available for this readout.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Functional Dizziness | Anxiety Symptoms in Functional Dizziness | -2.0 score on a scale |
Secondary
Depressive Symptoms in Functional Dizziness
Change from baseline in depressive symptoms of functional dizziness patients assessed by PHQ-9 questionnaires after 2±1 months Vertigoheel® treatment. The PHQ-9, ranging from 0 to 27 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months.
Time frame: 2 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Functional Dizziness | Depressive Symptoms in Functional Dizziness | -2.2 score on a scale |
Secondary
Postural Imbalance
Change from baseline in body sway assessed by static posturography after 2±1 months Vertigoheel® treatment. Posturography was assessed as described by Brandt et al. (J Neurol 2012, 259:182-4) with an artificial neural network analysis. Category three of the method for peripheral vestibular deficit was evaluated for patients with bilateral vestibulopathy, and category five for phobic postural vertigo was evaluated for patients with functional dizziness. Posturography was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. Positive values indicate more swaying and negative values indicate less swaying. The higher the value, the more swaying (worse regulation of stand). The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change).
Time frame: 2 months
Population: The postural imbalance data were available for 28 patients with functional dizziness and 13 patients with bilateral vestibulopathy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Functional Dizziness | Postural Imbalance | 2.8 arbitrary units |
| Bilateral Vestibulopathy | Postural Imbalance | 0.2 arbitrary units |
Secondary
Quality of Life (QoL)
Change from baseline in quality of life (QoL) assessed by EQ-5D-5L after 2±1 months Vertigoheel® treatment. The EQ-5D index was used as described by Ludwig et al. (PharmacoEconomics, 2018, 36:663-74), ranging from -0.661 to 1.000, with higher scores indicating better quality of life. QoL was assessed at two time points: baseline and 2 months.
Time frame: 2 months
Population: The QoL data were available for 31 patients with functional dizziness and 11 patients with bilateral vestibulopathy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Functional Dizziness | Quality of Life (QoL) | 0.121 units on a scale |
| Bilateral Vestibulopathy | Quality of Life (QoL) | 0.067 units on a scale |
Other Pre-specified
Vestibular Function in Bilateral Vestibulopathy by Caloric Testing
Change from baseline in vestibular function of bilateral vestibulopathy patients assessed by caloric testing after 2 ± 1 months of Vertigoheel® treatment. Caloric testing was performed as described by Strupp et al. (J Vestib Res. 2017;27(4):177-89) to evaluate the function of the vestibulo-ocular reflex (VOR) in the low-frequency range of the horizontal semicircular canal on each side. Bilaterally reduced angular VOR function is a diagnostic criterion for bilateral vestibulopathy (BVP). Reduced caloric response, i.e., a sum of both responses per ear \<6◦/sec, can be considered a safe criterion for BVP. Vestibular function was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change).
Time frame: 2 months
Population: Data from 11 patients were available for this readout.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Functional Dizziness | Vestibular Function in Bilateral Vestibulopathy by Caloric Testing | 5.5 arbitrary units |
Other Pre-specified
Vestibular Function in Bilateral Vestibulopathy by Video Head Impulse Test
Change from baseline in vestibular function of bilateral vestibulopathy patients assessed by video head impulse test (vHIT) after 2 ± 1 months Vertigoheel ® treatment. The vHIT was performed as described by MacDougall et al. (Neurology, 2009, 73(14):1134-41) to evaluate the function of the vestibulo-ocular reflex (VOR) in the high frequency range for the horizontal semicircular canals. Based on previous HIT data from healthy, asymptomatic subjects, a normal VOR velocity gain was defined as 0.68 or greater (MacDougall et al.2009). Vestibular function was assessed at two time points: baseline and 2 months. Reported values indicate the deviation from baseline values. The 2-month values were examined for significant differences from baseline values. One-sample t-Tests were used to compare mean change from baseline values versus zero (no change).
Time frame: 2 months
Population: Data from 12 patients were available for this readout.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Functional Dizziness | Vestibular Function in Bilateral Vestibulopathy by Video Head Impulse Test | -0.02 arbitrary units |